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Pioneer Surgical Technology
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PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) is an FDA 510(k)-cleared medical device (K043206) manufactured by Pioneer Surgical Technology. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 2005. Regulation: 8.